Safety Study of an Oral Vaccine to Prevent Seasonal Influenza

Vaxart

Status and phase

Completed

Phase 1

Conditions

Influenza

Treatments

Biological: VXA Placebo Tablet

Biological: VXA-A1.1 Oral Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01688297

VXA02-001 & VXA02-003

Details and patient eligibility

About

The purpose of this study was to demonstrate the safety and immunogenicity of an oral vaccine tablet to prevent seasonal influenza. The study was a placebo controlled, double blinded trial at a single site. The study was conducted under two separate protocols. Initially single administrations at two dose levels (low dose and mid dose) of the oral vaccine was tested in a placebo controlled study (37 subjects). And subsequently a single high dose of the oral vaccine was tested in a separate placebo-controlled study (24 subjects).

Full description

Low and mid dose study was conducted under protocol number VXA02-001

High dose study was conducted under protocol number VXA02-003

Enrollment

61 patients

Sex

All

Ages

18 to 49 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

In good health as established by medical history, physical examination, and laboratory testing at the time of enrollment.

Exclusion criteria

Positive for H1 influenza by HAI.
Has had an influenza vaccine in the past 2 years.
Current history of chronic alcohol consumption and/or illicit and/or recreational drug use.
History of any confirmed or suspected immunodeficient or immunosuppressive condition
Positive serology for HIV, HCV, or HBV
Previous serious reactions to vaccination such as anaphylaxis, respiratory problems, hives, or abdominal pain.
History of irritable bowel disease or other inflammatory digestive or gastrointestinal conditions that could affect the intended distribution of the vaccine targeting the mucosa of the small intestine
Use of proton pump inhibitors(Nexium, Prilosec).
Stool sample with occult blood at baseline exam

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

61 participants in 4 patient groups, including a placebo group

Low Dose VXA-A1.1 Oral Vaccine

Experimental group

Description:

Two doses of replication incompetent adenovirus vaccine given in an oral tablet formulation.

Treatment:

Biological: VXA-A1.1 Oral Vaccine

VXA Placebo Tablet

Placebo Comparator group

Description:

Oral tablets of the same size and number as the vaccine tablet doses. Placebo arms were included during enrollment of each of the experimental dose groups to maintain the double-blind study design.

Treatment:

Biological: VXA Placebo Tablet

Medium Dose VXA-A1.1 Oral Vaccine

Experimental group

Description:

Two doses of replication incompetent adenovirus vaccine given in an oral tablet

Treatment:

Biological: VXA-A1.1 Oral Vaccine

High Dose VXA-A1.1 Oral Vaccine

Experimental group

Description:

One dose of replication incompetent adenovirus given in an oral tablet dose. This dose was studied under protocol VXA02-003.